MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. (AF-MINNETONKA) REFLEXION SPIRAL BI-DIRECTIONAL CATHETER, 7F

Model Number D402893

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/05/2014

Event Type  Injury  

Event Description

During a pulmonary vein isolation procedure using a reflexion spiral ep catheter, the catheter dislodged an existing pacemaker lead.After the pulmonary veins had been isolated, an atrial tachycardia was induced in the patient.Based on the electrograms, the origination was in the right atrium, so the reflexion spiral ep catheter was withdrawn from the left atrium into the right atrium.The catheter was maneuvered to the lateral right atrium.Upon checking fluoroscopy, it was noted the existing right atrial lead had been dislodged.The patient underwent a right atrial lead revision with no complications.There were no performance issues with any sjm device.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the batch number was unavailable.Based on the info rec'd, the cause of the reported pacemaker lead dislodgement was procedure related.

• Brand Name: REFLEXION SPIRAL BI-DIRECTIONAL CATHETER, 7F
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (AF-MINNETONKA); minnetonka MN
• Manufacturer Contact: denise johnson, rn ; 177 east country road b; st. paul, MN 55117 ; 6517564071
• MDR Report Key: 3732892
• MDR Text Key: 4323406
• Report Number: 3005188751-2014-00042
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D402893
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SAFIRE BLU DUO ABLATION CATHETER (402871/LOT UNK); (407439/LOT UNKNOWN); (407439/LOT UNKNOWN); SWARTZ BRAIDED TRANSSEPTAL INTRODUCER,; SWARTZ BRAIDED TRANSSEPTAL INTRODUCER,
• Patient Outcome(s): Required Intervention